Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer

Phase 2

Terminated

• Conditions: Leukemia; Lymphoma; Malnutrition; Myelodysplastic Syndromes; Unspecified Childhood Solid Tumor, Protocol Specific; Weight Changes
• Interventions: Drug: cyproheptadine hydrochloride; Dietary Supplement: Ensure; Dietary Supplement: PediaSure

• Registration Number: NCT00949117
• Lead Sponsor: University of South Florida

Brief Summary

RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment.

PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.

Detailed Description

OBJECTIVES:

Primary

* To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending the duration of response in pediatric patients with cancer- or cancer treatment-related weight loss.

Secondary

* To compare patterns of body composition and weight change in patients treated with these regimens.

* To compare the change in the relationship between pre-albumin (biomarker of malnutrition) and weight improvement from baseline to the completion of study treatment.

* To compare the change in quality of life as measured by the Pediatric Functional Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center and steroid use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

* Arm II: Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

Patients undergo blood sample collection to assess pre-albumin levels at baseline and at weeks 4 and 24. Patients also undergo assessment of body composition, lean body mass, and percentage of body fat at baseline and at weeks 4 and 24 and assessment of weight and height at baseline and at weeks 4, 8, 12, 16, 20, and 24. Patients also complete a food diary twice a week during study treatment.

Patients 7-17 years of age complete a quality-of-life questionnaire at baseline and at weeks 4 and 24.

Study Timeline

• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Study Start: 2009-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-07-08
• Results First Submitted QC: 2014-01-30
• Status Verified: 2014-03
• Results First Posted: 2014-03-04
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I- cyproheptadine hydrochloride	cyproheptadine hydrochloride	Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
cyproheptadine HCl & PediaSure or Ensure	Ensure	Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
cyproheptadine HCl & PediaSure or Ensure	PediaSure	Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
cyproheptadine HCl & PediaSure or Ensure	cyproheptadine hydrochloride	Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Difference Between Measures of Weight at Baseline and at Week 24	24 weeks	Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.

Secondary Outcome Measures

Name	Time	Method
Body Mass Index as Assessed at Baseline and 24 Weeks	24 weeks	Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.
Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition	24 weeks
Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24	24 weeks
Change in Weight for Age Z-score From Baseline Through 24 Weeks	Baseline and 24 weeks	Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.